RESUMO
Introduction: One of the most debilitating symptoms of malignant pleural mesothelioma (MPM) is dyspnoea caused by pleural effusion. MPM can be complicated by the presence of tumour on the visceral pleura preventing the lung from re-expanding, known as trapped lung (TL). There is currently no consensus on the best way to manage TL. One approach is insertion of an indwelling pleural catheter (IPC) under local anaesthesia. Another is video-assisted thoracoscopic partial pleurectomy/decortication (VAT-PD). Performed under general anaesthesia, VAT-PD permits surgical removal of the rind of tumour from the visceral pleura thereby allowing the lung to fully re-expand. Methods and analysis: MesoTRAP is a feasibility study that includes a pilot multicentre, randomised controlled clinical trial comparing VAT-PD with IPC in patients with TL and pleural effusion due to MPM. The primary objective is to measure the SD of visual analogue scale scores for dyspnoea following randomisation and examine the patterns of change over time in each treatment group. Secondary objectives include documenting survival and adverse events, estimating the incidence and prevalence of TL in patients with MPM, examining completion of alternative forms of data capture for economic evaluation and determining the ability to randomise 38 patients in 18 months. Ethics and dissemination: This study was approved by the East of England-Cambridge Central Research Ethics Committee and the Health Research Authority (reference number 16/EE/0370). We aim to publish the outputs of this work in international peer-reviewed journals compliant with an Open Access policy. Trial registration: NCT03412357.
Assuntos
Neoplasias Pulmonares/cirurgia , Mesotelioma/cirurgia , Derrame Pleural Maligno/cirurgia , Neoplasias Pleurais/cirurgia , Pleurodese/métodos , Cirurgia Torácica Vídeoassistida/métodos , Adulto , Cateteres de Demora , Ensaios Clínicos Fase III como Assunto , Inglaterra/epidemiologia , Estudos de Viabilidade , Feminino , Humanos , Neoplasias Pulmonares/complicações , Neoplasias Pulmonares/mortalidade , Masculino , Mesotelioma/complicações , Mesotelioma/mortalidade , Mesotelioma Maligno , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Projetos Piloto , Derrame Pleural Maligno/etiologia , Derrame Pleural Maligno/mortalidade , Neoplasias Pleurais/complicações , Neoplasias Pleurais/mortalidade , Pleurodese/efeitos adversos , Pleurodese/instrumentação , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamanho da Amostra , Análise de Sobrevida , Cirurgia Torácica Vídeoassistida/efeitos adversos , Cirurgia Torácica Vídeoassistida/instrumentação , Resultado do TratamentoRESUMO
OBJECTIVE: Aortic valve replacement (AVR) can be performed either through full median sternotomy (FS) or upper mini-sternotomy (MS). The Mini-Stern trial aimed to establish whether MS leads to quicker postoperative recovery and shorter hospital stay after first-time isolated AVR. METHODS: This pragmatic, open-label, parallel randomized controlled trial (RCT) compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analyzed in the intent-to-treat population. RESULTS: In this RCT, 222 patients were recruited and randomized (n = 118 in the MS group; n = 104 in the FS group). Compared with the FS group, the MS group had a longer hospital length of stay (mean, 9.5 days vs 8.6 days) and took longer to achieve fitness for discharge home (mean, 8.5 days vs 7.5 days). Adjusting for valve type, sex, and surgeon, hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR, 0.874; 95% confidence interval [CI], 0.668-1.143; P = .3246) or time to fitness for discharge (HR, 0.907; 95% CI, 0.688-1.197; P value = .4914). During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group), 12 patients (10%) in the MS group and 7 patients (7%) in the FS group died (HR, 1.871; 95% CI, 0.723-4.844; P = .1966). Average extra cost for MS was £1714 during the first 12 months after AVR. CONCLUSIONS: Compared with FS for AVR, MS did not result in shorter hospital stay, faster recovery, or improved survival and was not cost-effective. The MS approach is not superior to FS for performing AVR.
Assuntos
Valva Aórtica/cirurgia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Esternotomia/métodos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Análise Custo-Benefício , Inglaterra , Feminino , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/economia , Custos Hospitalares , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Alta do Paciente , Recuperação de Função Fisiológica , Esternotomia/efeitos adversos , Esternotomia/economia , Fatores de Tempo , Resultado do TratamentoRESUMO
When viewing unfamiliar faces, photographs of the same person often are perceived as belonging to different people and photographs of different people as belonging to the same person. Identity matching of unfamiliar faces is especially challenging when the photographs are of a person whose ethnicity differs from that of the observer. In contrast, matching is trivial when viewing familiar faces, regardless of race. Viewing multiple images of an own-race target identity improves accuracy on a line-up task when the target is known to be present (Dowsett et al., 2016, Q J Exp Psychol, 69, 1), suggesting that exposure to within-person variability in appearance is key to face learning. Across three experiments, we show that viewing multiple images of a target identity also improves accuracy for other-race faces on target-present trials. However, viewing multiple images decreases accuracy (i.e., increases false alarms) on target-absent trials for both own- and other-race faces. We discuss the implications of our findings for models of face recognition and for forensic settings.